Medical device consultant training

Training/workshop for medical device consultants (§83 MPDG)

Contents:

• EU legal system for medical devices and in-vitro diagnostics
• Medical Device Regulation (MDR) and InVitro Diagnostics Regulation
• Medical Devices Implementation Act (MPDG)
• Medical Devices Operator Ordinance (MPBetreibV)
• How does a product become a medical device/in vitro diagnostic device?
• Medical Devices Consultant (MPDG)
• Cooperation with the PRRC (MDR and IVDR)
• Market surveillance/post-market surveillance (MDR and IVDR)

Short biographies of the speakers:

Cornelius Weber is a trained healthcare and nursing professional and has successfully completed a bachelor's degree in medical technology. He is currently completing a distance learning programme in Regulatory Affairs at the Technical University of Lübeck. At the same time, he is supporting the leap:up regulatory affairs team as a working student.

Katja Krempler holds a doctorate in biology and has also completed the LifeScience Management course at ATV in Leipzig. She has many years of experience in quality management, regulatory affairs and the authorisation of medical devices. After working as a regulatory manager and QMB in a Leipzig start-up, she has been supporting start-ups and SMEs at leap:up since 2024 - focussing on quality management systems, technical documentation and regulatory issues.